A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care (ACQUIRE-ICD)

A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and caRE of Patients With an Implantable Cardioverter Defibrillator

This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.

Study Overview

• Status: Completed
• Conditions: Distress; Implantable Defibrillator User
• Intervention / Treatment: Other: Supportive care

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Zealand University Hospital - Roskilde
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a first-time ICD or CRT-D
• ≥18 years of age

Exclusion Criteria:

• Subcutaneous ICD
• Upgrade from a pacemaker to ICD or CRT
• History of psychiatric illness other than affective/anxiety disorders
• Cognitive impairments (e.g. dementia)
• Left ventricular assist device (LVAD) or upcoming LVAD implant
• Under evaluation or on the waiting list for heart transplantation
• No e-mail address
• Inability to manage or cope with computer technology
• Insufficient knowledge of the Danish language
• Participation in other randomized controlled trials unless of a technical nature
• Irresponsible to ask patient to participate according to GCP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge	Other: Supportive care; Information, guidance, supportive care, and psychological intervention
No Intervention: Usual care; Implantable cardioverter defibrillator implant + usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device acceptance	Measured with the Florida Patient Acceptance Survey (FPAS)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health status (generic)	Measured with the Short Form Health Survey 12 items (SF-12)	12 and 24 months
Patient empowerment (ICD-EMPOWER)	Purpose-designed and disease-specific 14-item measure that measures patient empowerment	12 and 24 months
ICD patient concerns (ICDC)	8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient	12 and 24 months
Symptoms of anxiety	Generalized Anxiety Disorder scale (GAD-7)	12 and 24 months
Symptoms of depression	Patient Health Questionnaire (PHQ-9)	12 and 24 months
Health status (heart failure specific)	Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	12 and 24 months
Return to work	Purpose-designed questions	12 and 24 months
Time to first ICD therapy	Defined as ATP, cardioversion or shock	12 and 24 months
Time to first hospitalization due to a cardiac cause	Hospitalization due to a cardiac cause	12 and 24 months
Time to mortality	Mortality	12 and 24 months
Cost-effectiveness	Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions.	12 and 24 months

Collaborators and Investigators

• Sponsor: Susanne Schmidt Pedersen
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital; Aalborg University Hospital; University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Susanne S Pedersen, PhD, University of Southern Denmark

Publications and helpful links

General Publications

• Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Empowerment; Information
• Other Study ID Numbers: 31779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No